MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd¿ posiflush¿ saline xs 10 ml the packaging burst.There was no report of patient impact.The following information was provided by the initial reporter: we have received complaint (b)(4) for bd306572 (bd saline filled 10ml syringe xs), lot 3061553 in relation to ¿poor package of product¿.The customer stated, ¿we are having a lot of trouble with the batches of bd saline filled 10ml syringe xs, the serration is not very good and when we split the strips they are bursting open, and therefore cannot be used.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-aug-2023.H6: investigation summary: to aid in the investigation of this issue, one (1) picture sample and one (1) physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, damage was observed to the blister packaging.A device history record review was completed for provided material number 306572 and lot number 3061553.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.A significant amount of in process testing is performed during the manufacture of each posiflush lot produced.The blister pack machine operator checks (b)(4) units per hour and the secondary packing operator checks an additional (b)(4) units per hour.In addition, final inspections are performed on (b)(4) units per pallet by the quality control inspectors.There were no reports of poor perforation during any of these inspections.The preventative maintenance relating to the perforation blades was completed per specifications as well.Based on the investigation results and the nature of the defect, it is possible that the observed damage resulted from customer misuse.Previous investigations have identified that this defect may result from an incorrect method of separation.

Event Description

It was reported while using bd¿ posiflush¿ saline xs 10 ml the packaging burst.There was no report of patient impact.The following information was provided by the initial reporter: we have received complaint (b)(4) for bd306572 (bd saline filled 10ml syringe xs), lot 3061553 in relation to ¿poor package of product¿.The customer stated, ¿we are having a lot of trouble with the batches of bd saline filled 10ml syringe xs, the serration is not very good and when we split the strips they are bursting open, and therefore cannot be used.

• Brand Name: BD¿ POSIFLUSH¿ SALINE XS 10 ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17410905
• MDR Text Key: 320167364
• Report Number: 9616657-2023-00026
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 3061553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1